Perishable biological materials, including immunological and vaccine compositions, must often be frozen to low temperatures, including that of liquid nitrogen, during storage and shipping. As a consequence, vials must be labeled prior to the freezing process, since, prior to the present application, there was no device for automatically labeling vials while maintaining the cryogenic temperatures. In situations where vials or ampoules contain veterinary and pharmaceutical medications (e.g. immunological compositions, including vaccines), certain information such as the type of medicine, dosage amount, manufacturer, expiration date, etc. must be clearly imprinted on each vial to remain in compliance with the regulations of the various regulatory agencies. Additionally, the number of vials or ampoules filled and the lot from which material originated are also very important data points to mark and track. Prior art labeling techniques include printing onto a label, and then placing the label onto the vials. More recent efforts include printing directly onto the vials (see U.S. Pat. No. 7,647,867, to Byron). In another example, US 20140048066 A1 (to Holitas Limited) describes the labeling of nebulizer ampoules by laser-marking or laser-engraving data on a film to produce a data film and affixing the film onto a nebulizer ampoule using a non-migratory adhesive. To date, applicants are aware of no method that allows frozen vials or ampoules to be labeled, while still preserving the integrity and efficacy of the biological material contained therein.
For multi-national pharmaceutical companies, where the same product requires different labeling (i.e. owing to different languages and different regulatory requirements), the ability to label a filled, frozen vial would be highly desirable. The benefits to the supply chain are obvious (e.g. faster lead time, less waste, increased flexibility, etc.). Unfortunately, raising the temperature of a frozen vial to the temperatures normally associated with label application and/or printing is well-known to unacceptably reduce the biological activity of the vial's contents. Thus, the application of heated labels, as disclosed in US 2008/0178988 A1 (to Ambarsoumian), would subject the sensitive biological material to unacceptable heating. Moreover, any efforts in using a laser or other means to directly mark the glass of the vial or ampoule would almost certainly subject the frozen biological material to unacceptable heat stress.
Accordingly, there remains a long-felt need to develop a method to label vials containing frozen medicaments, including vaccines, while retaining the required biological activity, including immunological activity. This disclosure provides a solution to this long-felt need.